Aortic Aneurysm, Thoracic

5-Year Data from the AMDS DARTS Trial Demonstrates Positive Aortic Remodeling with 94% of Patients Free from Unanticipated Reoperation 30-Day Data from the AMDS PERSEVERE Trial Shows Cerebral Malperfusion Resolution in 90% of Affected Subjects Post-AMDS Implantation 1-Year Data from the NEOS Study Indicate E-vita Open Neo is Safe and Effective in the Treatment of Aortic Arch Pathologies with Low Combined Major Adverse Events Rate ATLANTA, Oct. 10, 2024 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced data from its AMDS DARTS and PERSEVERE trials and E-vita Open Neo study presented in Late-Breaking Science presentations at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Lisbon, Portugal. The presentation regarding the AMDS DARTS trial highlighted 5-year aortic remodeling data that demonstrate positive, durable patient outcomes following AMDS implantation. The presentation on the 30-day AMDS PERSEVERE trial data showed cerebral malperfusion resolution for 90% of affected subjects at 30-days post-AMDS implantation. Additionally, the presentation on the 1-year data from the NEOS study showed E-vita Open Neo is safe and effective for the treatment of acute and chronic aortic arch pathologies with a lower combined major adverse event rate compared to the market leading alternative. "We were thrilled to command such a strong presence at EACTS, with data from our AMDS and E-vita Open Neo clinical trials dominating the aortic focused late-breaking science session," said Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion. "Artivion remains committed to driving continued innovation in treating aortic disease, and these data further validate our best-in-class portfolio." Late-Breaking 5-Year Data from AMDS DARTS Trial: The abstract titled 5-Year Results on Aortic Remodeling in the Dissected Aorta Repair Through Stent (DARTS) Implantation Trial reports five years of clinical follow-up on the remaining 25 of 46 study participants with acute DeBakey Type I dissection who were treated with a proximal aortic repair and AMDS. The results demonstrate durable benefits out to at least 5 years over the baseline: 94% of patients were free from aortic reoperation compared to existing literature on hemiarch-only outcomes which report freedom from late aortic arch reoperation as low as 76%, 95% of patients were free from total aortic diameter (TAD) growth >5 mm between the 3-year and 5-year follow up periods at aortic zones 2 and 4; and In contrast, existing literature on hemiarch-only outcomes suggest a majority of patients have early TAD growth in the proximal descending aorta. Aortic growth can lead to increased risk of rupture or dissection, and reoperation. Principal investigator Dr. Michael Moon, Division of Cardiac Surgery, University of Alberta, Edmonton, Canada said, "Significant dilation of the ascending aorta, measured by changes to the TAD, increases the risk of spontaneous rupture or dissection of the aorta, a serious medical emergency. These long-term results from the DARTS study demonstrate a large majority of patients experience a stable or decreased TAD following treatment with AMDS, meaning these patients were successfully treated with AMDS and are at decreased risk for further aortic dissection and reoperation as far out as 5-years post implantation." Late-Breaking 30-Day Data from AMDS PERSEVERE Trial: The abstract titled AMDS Hybrid Prosthesis Improves Cerebral Malperfusion in Acute DeBakey Type I Dissection- Early Results of the PERSEVERE Study focuses on cerebral blood flow across the full 93 study participant IDE cohort at 30-days following AMDS implantation. 20% of patients (19 of 93 patients) presented with symptomatic pre-operative cerebral malperfusion including stroke, transient ischemic attack, delirium or other mental status changes. The 30-day data showed resolution of cerebral malperfusion in the vast majority of patients treated with AMDS. More specifically: 90% of patients experienced resolution of their cerebral malperfusion; and 63% of those who presented with cerebral malperfusion had complete resolution, while another 26% had no worsening of stroke symptoms The data compare favorably to hemiarch alone based on data from five articles in the literature, which showed a stroke occurrence rate of 20.9% compared to 10.8% (10 of 93 patients) in the PERSEVERE trial. Senior author, Dr. William Brinkman, Baylor Scott & White, The Heart Hospital Plano, Plano, Texas said, "Cerebral malperfusion, which often leads to stroke, is a devasting complication of Acute DeBakey Type I aortic dissection. The data from the PERSEVERE trial indicating that AMDS markedly reduces 30-day malperfusion and new disabling stroke compared to the baseline, is very encouraging." Late-Breaking 1-Year Data from E-vita Open Neo NEOS Study: The abstract titled E-vita Open Neo in the treatment of acute or chronic aortic pathologies: 1-year results of the European multicenter NEOS study and sub-group analysis includes 161 participants treated with E-vita Open Neo in Europe. The 1-year data suggests E-vita Open Neo is safe and effective in the treatment of aortic arch pathologies and compares favorably to the IDE study results of the current market leading device: The 1-year mortality rate observed for E-vita Open Neo (9.9%) compared favorably to current market leading device (10.8%); and Lower 1 year combined major adverse events rate of mortality, stroke, and paraplegia/ paraparesis occurring after treatment with E-vita Open Neo (17% vs 23.1% for current market leading device). Professor Martin Grabenwöger, Head, Department of Cardiovascular Surgery, Hietzing Hospital, Vienna, Austria said, "These exciting results from the NEOS study demonstrate the clinical benefits of E-vita Open Neo compare favorably to currently available options for treatment of aortic arch pathologies. This study is a major step forward in improving care for patients suffering from this life-threatening disease." About the AMDS DARTS Trial The AMDS DARTS (Dissected Aorta Repair Through Stent Implantation) trial is a prospective, multicenter, nonrandomized, single-arm trial of 47 patients evaluating the safety and efficacy of the AMDS Hybrid Prosthesis for the treatment of Acute DeBakey Type I (ADTI) dissection. Trial results supported regulatory approvals for AMDS in Canada, Europe, and other countries around the world. About the AMDS PERSEVERE Trial The AMDS PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial to determine if patients with ADTI dissection can be treated safely and effectively using the AMDS Hybrid Prosthesis. The trial is designed to support the company's forthcoming application to the U.S. Food and Drug Administration (FDA) for premarket approval of the AMDS. The trial consists of 93 participants in the U.S., who have experienced an ADTI dissection. Each participant will be followed for up to 5 years. The combined 30-day safety and primary efficacy endpoints were used to determine the impact of the AMDS Hybrid Prosthesis on DANE prevention, reducing mortality, new disabling stroke, new onset renal failure requiring dialysis, and myocardial infarction, as well as remodeling of the aorta. Full 30-day IDE data from the PERSEVERE trial presented at the Society of Thoracic Surgeons in January 2024, demonstrated statistically significant reduction in all-cause mortality and primary major adverse events (MAEs) at 30 days with use of AMDS in ADTI dissections complicated by malperfusion. Data from the trial also demonstrated a 72% reduction in all-cause mortality and 54% reduction in primary major MAEs when compared to the current standard of care hemiarch procedure. Data presented from the PERSEVERE trial at the 104th American Association for Thoracic Surgery (AATS) Annual Meeting April 2024, showed positive aortic remodeling at 30-days after treatment with AMDS, as well as no occurrence of distal anastomotic new entry (DANE) tears. More specifically, at 30 days, the majority of patients demonstrated favorable remodeling with over 80% showing either stable or decreased total aortic diameter (TAD). About the E-vita Open Neo NEOS Study The E-vita Open Neo NEOS study is an observational, multicenter study to determine the safety and clinical performance of E-vita Open Neo Stent Graft System in the treatment of acute and chronic aneurysm and dissection in the ascending aorta, aortic arch and descending thoracic aorta. The observational study consists of 161 patients with acute or subacute type A aortic dissection, chronic type A aortic dissection or thoracic aortic aneurysm enrolled at 12 centers in Europe and Asia December 2020 to March 2022. The primary end point was the rate of all-cause mortality at 30 days. The secondary end points included further clinical and safety data that are reported up to 3–6 months postoperatively. About Artivion, Inc. Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, . Contacts: SOURCE Artivion, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HERZELIA, Israel, July 2, 2024 /PRNewswire/ -- Endospan Ltd ("Endospan"), an Israeli-based, privately-held developer of the NEXUS® Stent Graft System ("NEXUS"), announced today an agreement with Artivion, Inc ("Artivion") for additional loans of up to $25M for U.S. Food and Drug Administration ("FDA") approval of NEXUS. "We're excited to progress in our IDE study with the FDA and extending options for more patients with aortic arch disease through this agreement with Artivion," Kevin Mayberry, chief executive officer of Endospan, said. "We share a commitment with Artivion to delivering minimally-invasive solutions to help surgeons address the complex challenges of this growing market." More than 120,000 patients suffer thoracic aortic arch disease every year in the USA and Europe, with only about 25% diagnosed or treated. Despite significant advancements, open surgical aortic arch repair maintains high mortality and morbidity. Patients with excessive perioperative risk or anatomical factors are not indicated for surgery, yet anatomical complexity and lack of approved devices for the arch has often prohibited endovascular repair. This makes the choice of treatment difficult or even impossible for some patients. Providing the alternative of minimally invasive repair decreases the requirement for extra corporal circulation and the possibility of hypothermia, translating into reduced procedure and hospitalization time. Endospan has developed NEXUS, the first and only approved branched endovascular system to treat aortic arch disease, including both aortic aneurysms and aortic dissections. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysm (TAA), aortic arch disease patients with aneurysms or dissections who receive treatment have previously had little choice but to undergo open-chest surgery with its associated invasiveness and risks, lengthy hospitalizations, and prolonged recuperation. NEXUS transforms a complex surgical aortic arch repair into a minimally invasive endovascular procedure. NEXUS addresses a $600M global addressable market opportunity. Endospan is currently enrolling patients in the TRIOMPHE IDE Study, a multi-arm, multi-center, non-randomized, prospective, clinical study to evaluate the safety and effectiveness of NEXUS® in treating thoracic aortic lesions involving the aortic arch. The study will enroll up to 110 patients at up to 31 sites. Earlier this year, Endospan shared 30-day results of the first 22 patients enrolled in the study. This early data aligned with results achieved during an EU clinical study, suggesting that NEXUS may provide surgeons with a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes. About Endospan Ltd. Privately held Endospan, headquartered in Herzelia (Tel Aviv), Israel, is a pioneer in the endovascular repair of Aortic Arch Disease including aneurysms and dissections. Endospan has received CE-Mark to commercialize in Europe the NEXUS™ Stent Graft System, the first endovascular off-the-shelf system to treat aortic arch disease which affects a greatly underserved group of patients diagnosed with a dilative lesion in, or near, the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), aortic arch disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website, . About Artivion, Inc. Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, . Endospan Kevin Mayberry Chief Financial Officer [email protected] SOURCE Endospan

In its first 12 months, the surveillance program has led to 35 life-saving TAA surgical procedures. OVERLAND PARK, Kan., Feb. 20, 2024 /PRNewswire/ -- Softek Illuminate, Inc., provider of enterprise follow-up management and discovery software, and UC Davis Health have developed a centralized Thoracic Aortic Aneurysm (TAA) surveillance program that is saving lives. The effort has identified at-risk patients who may have been 'lost-to-follow-up' because they missed care due to numerous factors. This new program builds on the previously announced success between Illuminate and UC Davis Health with a centralized Abdominal Aortic Aneurysm (AAA) program. This new TAA program will further advance efforts to make it easier for care navigators to manage vascular patients with critical follow-up care requirements. In the first 12 months of the program, which kicked-off December 2022, over 21,700 patients have been identified with some mention of TAA who could benefit from ongoing surveillance. Over 12,200 TAA patient records were then reviewed and 2,390 patients who were lost to care are now under active surveillance and management by nurse navigators. Of those, 146 patients visited UC Davis Health, which resulted in 461 diagnostic imaging studies and 35 life-saving TAA surgical procedures. "Through the TAA surveillance program, we have been able to improve patient outcomes by reducing the risk of a patient experiencing an aneurysm rupture by offering TAA repair when appropriate," said Misty Humphries, interim chief of Vascular Surgery at UC Davis Health. "This is but one example of how we are using cutting edge software technology to improve patient care and clinical outcomes." According to the Society for Vascular Surgery, each year 15,000 people in the United States are diagnosed with a TAA. As a leading academic medical center with a patient-centered focus on digital health, UC Davis Health has implemented the Discovery 360 Platform and ActKnowledge AI software by Illuminate. The goal is to identify existing patients in the UC Davis electronic health record who may have a TAA and who need follow-up care. Identified patients are then contacted by a UC Davis Health nurse navigator who explains the program and the process. The nurse also educates the patient about the importance of follow-up and ongoing surveillance by their primary care physician and serves as an educational resource for the patient when they have additional questions. Along with Illuminate AI technology and clinical process understanding, the Illuminate Discovery 360™ Platform incorporates skilled Illuminate nurse navigators with expertise in patient follow-up and management workflow. Their participation can lower the barrier for implementing a comprehensive aneurysm surveillance program and ensure the following benefits are realized: Improve Follow-Up Compliance. Eliminate Gaps in Care. Align follow-up care with health system care guidelines. Retain Patients In-Network and Reducing Leakage. Avert Ruptures and Saves Lives. "We are excited about our expanded relationship with UC Davis Health and these very positive results that align with our previous success in the AAA space," states Cole Erdmann, CEO, Softek Illuminate, Inc.. About Softek Illuminate, Inc. Illuminate is the industry-leading provider of end-to-end discovery, follow-up, and patient management solutions. We achieve this by combining our advanced AI-powered patient management platform with our nurse navigator's knowledge of integrated clinical workflows and follow-up processes. The Illuminate Platform enables healthcare organizations to provide the highest quality and most cost-effective care while growing revenue throughout the patient journey. Illuminate simplifies the process of ensuring that the right care team manages the appropriate patients at the right time. To learn more, visit . SOURCE Softek Illuminate, Inc.